ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01971593
Recruitment Status : Terminated (Investigator left institution)
First Posted : October 29, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Tetralogy of Fallot
Transposition of the Great Vessels With an Arterial Switch
Single Ventricle With a Fontan Palliation
Intervention: Drug: Eplerenone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eplerenone After Drug Free Period

Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period

Eplerenone

Eplerenone Before Drug Free Period

Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period

Eplerenone


Participant Flow:   Overall Study
    Eplerenone After Drug Free Period   Eplerenone Before Drug Free Period
STARTED   14   12 
COMPLETED   9   8 
NOT COMPLETED   5   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Group Crossover study, all patients pooled for baseline analysis

Baseline Measures
   Total Study Group 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      26 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  34.6% 
Male      17  65.4% 
Tetralogy of Fallot 
[Units: Participants]
Count of Participants
 12 
Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV) 
[Units: Participants]
Count of Participants
 14 


  Outcome Measures

1.  Primary:   Procollagen N-terminal Peptide 1   [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]

2.  Primary:   Procollagen III N-Terminal Peptide   [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]

3.  Primary:   Galectin 3   [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]

4.  Secondary:   6 Minute Walk   [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]

5.  Secondary:   Quality of Life   [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]

6.  Other Pre-specified:   Serum Creatinine   [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Incomplete study enrollment led to inadequate power to derive reliable conclusions.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ari Cedars
Organization: UT Southwestern
phone: 3149224788
e-mail: acedars97@gmail.com



Responsible Party: Ari Cedars, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01971593     History of Changes
Other Study ID Numbers: WI170964
First Submitted: October 23, 2013
First Posted: October 29, 2013
Results First Submitted: January 25, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018